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ADVIA Centaur HBc Total 2 (HBcT2)

IVDR_67_LLB_DUB-C_D_KIT_HBc Total 2

IVD Class DIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Products Ltd.
Manufacturer SRN: GB-MF-000016339
UDI-DI: 00630414561226
Basic UDI-DI: 0405686901498W9
Reference: 10376698
EMDN: W0105020208
EMDN description: HEPATITIS B CORE ANTIBODY (TOTAL)
First on market country: Germany
Safety summary (SSCP/SSP): SSP_ADVIA Centaur_HBcT2_HBcT2 QC · Rev. 4.0
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 24.09.2026 08:52

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

ADVIA Centaur Anti-HBs2 (aHBs2) Quality Control

IVDR_67_TTN_DUB-C_D_REAG_Anti-HBs2 QC

IVD Class DIVDR 2017/746On the marketHuman tissuesProfessional testingReagentSingle use

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414551777
Basic UDI-DI: 0405686901890WD
Reference: 10283088
EMDN: W0105080802
EMDN description: HEPATITIS VIRUS CONTROLS - INF.IMM.
First on market country: Germany
Safety summary (SSCP/SSP): SSP_ADVIA Centaur_aHBs2_aHBs2 QC · Rev. 5.0
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 24.09.2026 08:52

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

ADVIA Centaur CHIV

IVDR_67_TTN_DUB-C_D_KIT_HIV Ag/Ab Combo

IVD Class DIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414551487
Basic UDI-DI: 0405686901884WJ
Reference: 10283020
EMDN: W0105030404
EMDN description: HIV MULTIPLE AG/AB COMBI TEST
First on market country: Germany
Safety summary (SSCP/SSP): SSP_ADVIA Centaur_CHIV_CHIV QC · Rev. 6.0
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 24.09.2026 08:52

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

ADVIA Centaur HBeAg (HBe) Quality Control

IVDR_67_TTN_DUB-C_D_REAG_Hepatitis B e Antigen QC

IVD Class DIVDR 2017/746On the marketHuman tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414510668
Basic UDI-DI: 0405686901896WR
Reference: 10291296
EMDN: W0105080802
EMDN description: HEPATITIS VIRUS CONTROLS - INF.IMM.
First on market country: Germany
Safety summary (SSCP/SSP): SSP_ADVIA Centaur_HBeAg_HBeAg QC · Rev. 4.0
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 24.09.2026 08:52

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

ADVIA Centaur Hepatitis B e Antigen

IVDR_67_TTN_DUB-C_D_KIT_HBeAg

IVD Class DIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414510651
Basic UDI-DI: 0405686901880WA
Reference: 10291295
EMDN: W0105020211
EMDN description: HEPATITIS B ANTIGEN
First on market country: Germany
Safety summary (SSCP/SSP): SSP_ADVIA Centaur_HBeAg_HBeAg QC · Rev. 4.0
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 24.09.2026 08:51

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

ADVIA Centaur HCV Quality Control

IVDR_67_TTN_DUB-C_D_REAG_aHCV QC

IVD Class DIVDR 2017/746On the marketHuman tissuesProfessional testingReagentSingle use

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414473178
Basic UDI-DI: 0405686901888WS
Reference: 10309062
EMDN: W0105080802
EMDN description: HEPATITIS VIRUS CONTROLS - INF.IMM.
First on market country: Germany
Safety summary (SSCP/SSP): SSP_ADVIA Centaur_HCV_HCV QC · Rev. 4.0
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 24.09.2026 08:51

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

ADVIA Centaur® HCV

IVDR_67_TTN_DUB-C_D_KIT_aHCV

IVD Class DIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414473161
Basic UDI-DI: 0405686901874WF
Reference: 10309061
EMDN: W0105020301
EMDN description: HCV ANTIGEN
First on market country: Germany
Safety summary (SSCP/SSP): SSP_ADVIA Centaur_HCV_HCV QC · Rev. 4.0
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 24.09.2026 08:51

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

ADVIA Centaur HBsAg Quality Control Material

IVDR_67_TTN_DUB-C_D_REAG_HBsAg Quality Control

IVD Class DIVDR 2017/746On the marketHuman tissuesProfessional testingReagentSingle use

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414472881
Basic UDI-DI: 0405686901895WP
Reference: 10309059
EMDN: W0105080802
EMDN description: HEPATITIS VIRUS CONTROLS - INF.IMM.
First on market country: Germany
Safety summary (SSCP/SSP): SSP_ADVIA Centaur_HBsAgII_HBsAg Conf_QC · Rev. 10.0
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 24.09.2026 08:51

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

ADVIA Centaur HBsAg Confirmatory (Conf)

IVDR_67_TTN_DUB-C_D_REAG_HBsAg Confirmatory

IVD Class DIVDR 2017/746On the marketAnimal tissuesHuman tissuesProfessional testingReagentSingle use

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414472874
Basic UDI-DI: 0405686901881WC
Reference: 10309058
EMDN: W0105020202
EMDN description: HEPATITIS B SURFACE ANTIGEN - CONFIRMATORY
First on market country: Germany
Safety summary (SSCP/SSP): SSP_ADVIA Centaur_HBsAgII_HBsAg Conf_QC · Rev. 10.0
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 24.09.2026 08:51

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

ADVIA Centaur HBc IgM (aHBcM) Quality Control

IVDR_67_TTN_DUB-C_D_REAG_aHBcM QC

IVD Class DIVDR 2017/746On the marketHuman tissuesProfessional testingReagentSingle use

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414470504
Basic UDI-DI: 0405686901887WQ
Reference: 10308979
EMDN: W0105080802
EMDN description: HEPATITIS VIRUS CONTROLS - INF.IMM.
First on market country: Germany
Safety summary (SSCP/SSP): SSP_ADVIA Centaur_aHBcM_aHBcM QC · Rev. 4.0
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 24.09.2026 08:50

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

ADVIA Centaur® HBc IgM

IVDR_67_TTN_DUB-C_D_KIT_aHBcM

IVD Class DIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414470498
Basic UDI-DI: 0405686901872WB
Reference: 10308978
EMDN: W0105020210
EMDN description: HEPATITIS B CORE ANTIBODY IGM
First on market country: Germany
Safety summary (SSCP/SSP): SSP_ADVIA Centaur_aHBcM_aHBcM QC · Rev. 4.0
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 24.09.2026 08:50

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

Atellica IM HIV Ag/Ab Combo Quality Control (CHIV QC)

IVDR_67_TTN_DUB-C_D_REAG_ HIV Ag/Ab Combo QC

IVD Class DIVDR 2017/746On the marketHuman tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414229010
Basic UDI-DI: 0405686901886WN
Reference: 11200769
EMDN: W0105080803
EMDN description: RETROVIRUS CONTROLS - INF.IMM.
First on market country: Germany
Safety summary (SSCP/SSP): SSP_ADVIA Centaur_CHIV_CHIV QC · Rev. 6.0
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 24.09.2026 08:49

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

PreventID® Influenza A+B

IVD generalIVDDOn the marketKitNear-patient testingSingle use

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598013377
Basic UDI-DI: B-04050598013377
Reference: KST50112GP
EMDN: W0105040604
EMDN description: INFLUENZA & PARA INFLUENZA
First on market country: Germany
Authorised representative: -
Last updated: 24.09.2026 08:26

Manufacturer products View details

ChainFor™

Neisseria meningitidis Genotyping qPCR Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684998277358
Basic UDI-DI: 868499827PCR113YH
Reference: CFP113P100
EMDN: W0105010203
EMDN description: GONOCOCCAL DETECTION BY NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 24.09.2026 07:44

Manufacturer products View details

ChainFor™

H.pylori/Clarithromycin Genotyping qPCR Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684998276412
Basic UDI-DI: 868511580PCR144GP
Reference: 08684998276412
EMDN: W0105050399
EMDN description: OTHER PARASITOLOGY - NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 24.09.2026 07:44

Manufacturer products View details

LyoSens™

CMV Quantitative qPCR Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684998275132
Basic UDI-DI: 868499827PCR109YS
Reference: LYO109WS48
EMDN: W0105040205
EMDN description: CMV - NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 24.09.2026 07:44

Manufacturer products View details

RapidFor™

SARS-CoV-2 + FLU A/B + RSV + ADV Test Kit

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684998274302
Basic UDI-DI: 868354825VMD79SC4C
Reference: VMD79TD
EMDN: W0105090699
EMDN description: OTHER MULTIPLE PATHOGENS - RT & POC
First on market country: Türkiye
Authorised representative: -
Last updated: 24.09.2026 07:43

Manufacturer products View details

ChainFor™

Respiratory v2.0 Genotyping qPCR Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684998273503
Basic UDI-DI: 868511580PCR102G7
Reference: CFP102P50
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 24.09.2026 07:43

Manufacturer products View details

ChainFor™

Respiratory v1.0 Genotyping qPCR Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684998273497
Basic UDI-DI: 868511580PCR101G5
Reference: CFP101P50
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 24.09.2026 07:43

Manufacturer products View details

LyoSens™

Dengue/Chikungunya/Zika Genotyping qPCR Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684595037577
Basic UDI-DI: 868511580PCR92JR
Reference: LYO92WS24
EMDN: W0105070302
EMDN description: OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 24.09.2026 07:43

Manufacturer products View details